Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease

University Hospital of Ferrara20 enrolled

Overview

The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease

Interventions

Virtual RealityBEHAVIORAL

12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks

Conventional TherapyBEHAVIORAL

12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * idiopathic Parkinson Disease diagnosis * age under 80 years * severity of disease rated 2 or 3 at Hoehn \& Yahr scale Exclusion Criteria: * impaired cognitive functioning: score less than 24 on the Mini Mental State Examination * neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol * severe Levodopa dyskinesia * pregnancy

Locations (1)

Ferrara University Hospital

Ferrara, Italy

RECRUITING

Outcomes

Primary Outcomes

Six-Minute Walking Test

The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary.

Time frame: up to weeks 16

Secondary Outcomes

Berg Balance Scale

This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale.

Time frame: weeks: 0,4, 16

Time Up and Go Test

Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch.

Time frame: weeks: 0,4, 16

10 meter walk test

Assesses walking speed in meters per second over a short duration

Time frame: weeks: 0,4, 16

Unified Parkinson's Disease Rating Scale

It is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease across the longitudinal disease course and provide a clinical endpoint in therapy trials.

Time frame: weeks: 0,4, 16

Postural sway (Center of pressure (COP) trajectories)

Center of pressure (COP) trajectories

Time frame: weeks: 0,4, 16

Metabolic measurements by Near infrared spectroscopy

Central Contacts

Sofia Straudi, MD

CONTACT

+390532238720 s.straudi@ospfe.it

Data from ClinicalTrials.gov

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